Abstract
e18508 Background: Immunotherapy is the standard of care in the treatment of platinum-refractory recurrent/metastatic head and neck squamous cell carcinoma (R/M-HNSCC). Previous loco-regional treatment could have an impact on the immune system and response to Nivolumab. The aim of this study is to evaluate the efficacy and safety of Nivolumab in a real world population, identifying the impact of the clinic-pathological characteristics and previous treatment in prediction of early progression. Methods: This is a observational, multicenter retrospective/prospective study including patients (pts) with platinum refractory R/M HNSCC who received Nivolumab 240 mg every 2 weeks until disease progression or unacceptable toxicity, from October 2018 to October 2019. We analyzed treatment outcomes in term of early progression (within 3 months), clinical benefit, progression free survival (PFS) and overall survival (OS). To determine the influence on outcomes, the following variables were investigated: primary tumor sub-site, age, gender, ECOG, previous loco-regional treatment, previous systemic therapy, metastatic site. Results: Data from 61 pts were reviewed: 15 oral cavity, 14 oropharynx, 7 hyphofarynx, 19 larynx, 6 paranasal sinus. Median age was 66 years (29-82), 48 pts were men. Forty-nine pts (80%) had performance status (ECOG) ≥ 1 at baseline evaluation. Eleven pts (18%) had only loco-regional recurrence, while 50 pts (82%) had one or more metastatic site. 32 (52%) and 17 pts (28%) had smoking and alcohol abuse history, respectively. 44 pts (72%) received surgery followed by adjuvant radiant treatment at standard dose (28, 46%) or concomitant definitive radiotherapy (16, 26%) as upfront treatment with curative intent. With a median follow up of 4 months (range 1-11), early progression occurred in 39 pts during Nivolumab treatment (64%), while clinical benefit (stable disease and partial response) was achieved in 22 pts (36%). No G3-G4 toxicities occurred. Early progression to Nivolumab was significantly associated to previous loco-regional treatment both at univariate and multivariate analysis (p=0.003 and p= 0.04, respectively). Conclusions: Nivolumab in R/M HNSCC is effective and safe even though burdened with a high early progression rate. Loco-regional treatment, including wide neck dissection and high dose radiotherapy, may compromise the efficacy of Nivolumab, distorting the anatomy of the local lymphatic system and hindering the priming of immune response.
Highlights
Head and neck cancer represents the sixth most common type of neoplasia worldwide with650,000 new cases and around 330,000 deaths each year [1]
Radical surgery with the demolition of the complex lymphatic network of the neck associated with adjuvant high dose radio-chemotherapy or primary radio-chemotherapy, carried out for reducing local recurrence and improve disease control, radically modify the anatomy of the local lymphatic system, hindering the priming of immune response (Figure 2)
The first postoperative phase is characterized by the increase of cytokines of wound healing, programmed death ligand-1 (PD-L1) expression, myeloid-derived is characterized by the increase of cytokines of wound healing, PD-L1 expression, myeloid-derived suppressor cells (MDSC), macrophages M2, and Treg
Summary
Head and neck cancer represents the sixth most common type of neoplasia worldwide with650,000 new cases and around 330,000 deaths each year [1]. The vast majority (more than 90%) of head and neck cancer are squamous cell carcinoma arising from various subsites of the upper aerodigestive tract. These cancers are strongly associated to specific risk factors such as tobacco and alcohol intake and human papilloma virus (HPV) infection, the latter defining a distinct disease entity [2]. In the pre-immunotherapy era, the diagnosis of unresectable recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC) was linked to an invariably poor prognosis with an expected survival of less than 1 year [3]. Previous locoregional treatment could a↵ect the response to nivolumab in platinum-refractory recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). Previous wide neck dissection and high dose radiotherapy may compromise the efficacy of nivolumab, distorting the anatomy of the local lymphatic system and hindering the priming of immune response
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